NCT04437875

An Open Study of the Safety, Tolerability and Immunogenicity of "Gam-COVID-Vac Lyo" Vaccine Against COVID-19

An Open Study of the Safety, Tolerability and Immunogenicity of the Drug "Gam-COVID-Vac Lyo" Lyophilizate for the Preparation of a Solution for Intramuscular Injection With the Participation of Healthy Volunteers

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

the purpose of this study: to evaluate the safety, tolerability and immunogenicity of the drug "Gam-COVID-Vac Lyo", a lyofilizate for preparing solution for intramuscular administration, at various times after vaccination in healthy adult volunteers.

Detailed description

An open two stage non-randomized Phase 1 study with the participation of healthy volunteers. This clinical trial is an open study of safety, tolerability and immunogenicity of the drug "Gam-COVID-Vac Lyo", lyophilisate for the preparation of a solution for intramuscular administration, with the participation of healthy volunteers. Study objectives 1. A safety and tolerability assessment of the drug "Gam-COVID-Vac Lyo", lyophilisate for the preparation of a solution for intramuscular administration, using single dose of each component (Stage 1). 2. A safety and tolerability assessment of the drug "Gam-COVID-Vac Lyo", lyophilisate for the preparation of a solution for intramuscular administration, using prime-boost immunization according to the proposed scheme (Stage 2). Study Design Stage 1 the First group, 9 volunteers, will receive the drug, a solution for intramuscular administration, in the mode of single immunization with component 1 in a full therapeutic dose. the Second group, 9 volunteers, will receive the drug, a solution for intramuscular administration, in the mode of single immunization with component 2 in the full therapeutic dose. The studied drugs will be administered to a total of 18 volunteers in a hospital setting and after administration, the drug's safety will be continuously monitored for 5 days. Based on the results of the safety assessment, the Chief investigator decides to proceed to the second stage of the study on the 5th day after the introduction of the studied drugs. Second stage The second stage will include 20 volunteers and three understudies. Volunteers of the second stage will be vaccinated no earlier than 5 days after vaccination of participants of the first stage. Volunteers participating in the second stage of the study (a total of 20 people) will receive the study drug according to the booster scheme: the introduction of component 1 will be carried out on day 1, and component 2-on the 21st day of the study. Follow-up will be carried out during 4 visits: on 7, 14, 28, 42 days after administration of the drug. Throughout the inpatient observation and the follow-up period (180 days) of visits during the entire study, safety information will be collected

Conditions

• Preventive Immunization COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Gam-COVID-Vac Lyo	adenoviral-based vaccine against SARS-CoV-2

Timeline

• Start date: 2020-06-17
• Primary completion: 2020-08-03
• Completion: 2020-08-10
• First posted: 2020-06-18
• Last updated: 2020-08-12

Locations

1 site across 1 country: Russia